May 12, 2017 — A new research study concluded that use of the BioZorb surgical marker appears to provide better cosmetic outcomes and may be associated with an increased use of breast-conserving surgery. The study was conducted by Arkansas surgical oncologist Michael Cross, M.D., F.A.C.S.

The study found that more than 90 percent of patients who received the implant as part of their surgery experienced either excellent or good cosmetic results, as rated by both patients and their physicians. Cross has been using the U.S. Food and Drug Administration (FDA)-cleared marker since 2012.

His scientific poster was presented at the 2017 American Society of Breast Surgeons annual meeting, April 26-30 in Las Vegas. Cross has in previous studies also reported a trend toward shorter courses of radiation therapy in cases where patients were treated through breast-conserving lumpectomy surgery.

"If we can deliver less overall radiation with better cosmetic results and just as good survival rates, then it's a win-win-win scenario," said Cross.

This observational, retrospective study encompassed a total of 1,115 patients who underwent breast cancer surgery between 2011 and 2016. The use of lumpectomy in Cross's practice increased by 27.7 percent during the study period.

In 2011-2013 — the period before the marker was used routinely in the practice's breast surgeries — Cross performed 540 breast cancer surgeries and the lumpectomy rate was 37.7 percent. During 2014-2016 when the device was consistently used, he performed 575 breast cancer surgeries and the lumpectomy rate was 48 percent.

Because Cross's data is from a single practice with a largely rural patient population, he said further research was needed to see if his results are generalizable to other practices that serve patients with different characteristics.

The BioZorb implant is sutured into the tumor site and is the first device that identifies where the breast cancer tumor was removed in a fixed, three-dimensional manner. After lumpectomy surgery, the implant helps the radiation oncologist plan treatments more reliably and determine where to aim the radiation in a more targeted fashion.

The implant consists of a framework made of a bioabsorbable material that holds six titanium clips. The framework of the device slowly dissolves in the body over the course of a year or more while the small marker clips remain at the surgical site and can be viewed for long-term monitoring such as mammograms. Studies have reported the rate of complications such as infection (2-3 percent) is virtually the same as for lumpectomy surgery without the implant.

The favorable cosmetic results with the device are due in part to its advantages for oncoplastic surgery (OPS), Cross said. OPS emphasizes both cancer control and a better cosmetic outcome. It reconstructs and reshapes the breast to avoid deformities that can occur after healing from surgery and radiation.

"Because of the BioZorb's shape, it helps me use the patients' own tissue for reconstruction at the time of lumpectomy — so I like to use the term 'reconstructive lumpectomy' when I explain what the surgery will entail," Cross said. "In my practice, this is now the routine standard with appropriately selected patients." The marker enhances oncoplastic surgery because it helps fill the space left by the tumor removal, while also providing a sort of scaffold for the breast tissue as it heals.

In addition, the implant clearly delineates the tumor's previous location. This enables follow-up radiation therapy to be delivered more precisely, according to previous studies of the device. Better-targeted radiotherapy can have a positive impact on cosmetic outcomes and can help protect healthy body structures such as the heart and lungs from radiation exposure.

Cross said the ability to deliver shorter, hypofractionated radiation therapy provides a substantial benefit for his patient population. This shorter course of radiation allows women to receive their radiation therapy over three to four weeks, instead of the usual five to six weeks.

Many of his patients live far from Fayetteville and have to travel several hours to the city. Patients who receive hypofractionated radiation therapy have to travel far less often for treatment. The ability to get a shorter course of radiation may lead more women to choose breast-conserving surgery (BCS) instead of a mastectomy. (BCS is usually followed up with radiation therapy, while a mastectomy normally is not.)

Focal Therapeutics, which makes the BioZorb device, provided writing and research support for Cross's presentation.